Intranasal Retinoic Acid Treatment for Patients With OlfactoryLOSS: A RANDOMIZED CONTROLLED TRIAL

NCT03574701 | Unknown

• 1 other identifier: H15-02095
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

About One to 2 percent of the North American population below the age of 65 years experience olfactory loss to a significant degree. It can result from advanced age, Post-infestious/inflammatory disorders, Obstructive disorders (e.g. nasal polyposis, tumors), posttraumatic (head trauma) and neurodegenerative disorders. Only a few studies have shown benefits of specific therapy for olfactory loss. Vitamin has shown promise from both animal and human studies. However, none has studied the benefits of topical application of vitamin A. This study will be the first to examine this effect.

Conditions

Olfactory Disorder

Keywords

olfactory; Vitamin A; Olfactory training; CRS

Outcome Measures

Primary Outcomes (1)

• Olfactory Tests.

  These tests will be performed by same blinded assessor using the "Sniffin sticks" kit described above. The test is divided into three subtests including tests for olfactory thresholds (using phenyl ethyl alcohol), odor discrimination, and odor identification (TDI). The sum of the three scores reliably indicates the degree of olfactory function.

  For each subject this test will take 30 minutes

Secondary Outcomes (3)

• Sinonasal Outcomes Test - 22 (SNOT-22)

  For each subject this test will take between 5-10 minutes.

• Sinus Mucosal Inflammation - Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)

  For each subject this test will take about 5 minutes.

• Questionnaire of Olfactory Disorders

  For each subject this test will take about 10 minutes.

Study Arms (3)

A: Vitamin A and Olfactory Retraining

EXPERIMENTAL

Group A: This study group will receive intranasal vitamin A at 10,000 I.U. per day and olfactory retraining using scented oils in addition to their standard of care.

Dietary Supplement: Vitamin A

B: Vitamin A

EXPERIMENTAL

Group B: This study group will receive Vitamin A in addition to their standard of care. They will not receive olfactory retraining.

Dietary Supplement: Vitamin A

C: Standard of Care

NO INTERVENTION

Group C: This study group will receive only standard of care .

Interventions

Vitamin A DIETARY_SUPPLEMENT

The use of Vitamin A , in the treatment of olfactory loss has been previously studied in both animals and humans. These studies have shown promising results in the treatment of olfactory loss.

Also known as: Essential oils

A: Vitamin A and Olfactory Retraining; B: Vitamin A

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 19 years and above diagnosed with loss of olfactory function, (with or without history of sinonasal surgery) currently receiving sinonasal-related care at the St Paul's Sinus Centre.

You may not qualify if:

• Patients with Primary anosmia.
• Patients with baseline olfactory test scores \>30 using Sniffin sticks test.
• Patients with sinonasal tumors
• Patients with polyps or significant inflammation blocking access of medication to the olfactory cleft.
• Patients allergic to topical Vitamin A
• Cystic fibrosis or syndromic patients
• Patients with autoimmune diseases that have sinus manifestations or affect sinus function
• Patients with previous history of hypervitaminosis A
• Patients with Neurological Disease (e.g. stroke history, Parkinson's disease)
• Patients who are pregnant

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (2)

St Paul Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

St Paul Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Anosmia

Interventions

Vitamin A; Oils, Volatile

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Oils; Lipids

Study Officials

• Amin Javer, MD FRCSCFARS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amin Javer, MD

CONTACT

6048069926; sinusdoc@me.com

Sara Derikvand, PhD

CONTACT

6048069926; stpaulsinusresearch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, St. Paul's Sinus Centre

Model Details: The patients will be randomized into 3 groups using the sealed envelope method. Each patient will be his or her own control. There will be two possible scenarios resulting from randomization: * Group A: This study group will receive intranasal vitamin A at 10,000 I.U. per day and olfactory retraining using scented oils in addition to their standard of care. * Group B: This study group will receive Vitamin A in addition to their standard of care. They will not receive olfactory retraining. * Group C: This study group will receive only standard of care .

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 2, 2018
• Study Start: May 25, 2016
• Primary Completion: December 25, 2021
• Study Completion: December 25, 2022
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CA (2)